Tobacco, the FDA, and Preemption

Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco products. Antitobacco activists are cheering, while some tobacco companies are raising the specter of First Amendment violations. Lost in the debate is the fact that this bill will continue to allow consumers to sue manufacturers that fully comply with the FDA’s content and labeling rules.

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Today’s legislation would impose strict limits on tobacco advertising and labeling, mandate stronger warning labels, and require advance FDA approval of any reduced-risk claims. It would also empower the FDA to change cigarettes’ content to make them less addictive and lethal.

However, in a little-noticed provision, the bill also expressly provides that “no provision of this chapter . . . shall be construed to modify or otherwise affect . . . the liability of any person under the product liability law of any State.” In other words, the regulatory regime that the legislation would establish can’t protect companies from tort liability — even if they rigorously follow every FDA rule.